New Phase III Data in Asthma Patients Show Tiotropium Improves Lung Function, Regardless of Allergic Status

Boehringer Ingelheim has presented data on investigational tiotropium delivered via Respimat inhaler from five Phase III trials from the UniTinA-asthma programme at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas. Pre-planned analyses from the programem, including new data from the GraziaTinA study, showed that the addition of tiotropium Respimat in adult patients with mild, moderate and severe asthma who continue to experience symptoms despite the use of maintenance therapies, improved lung function as measured by peak forced expiratory volume in one second (FEV(1) ((0-3hr))) and trough FEV(1), independent of underlying allergic status. Tiotropium is being investigated to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

"A significant number of asthma patients continue to experience symptoms despite treatment with available therapies and it is important to understand how a patient's allergic status might impact their response to treatment," said Kevin Murphy, Boys Town National Research Hospital, Omaha, Nebraska. "These data showed that the addition of tiotropium delivered via Respimat inhaler improved lung function in adults with asthma across a range of severities independent of underlying allergic status."

Tiotropium is being studied as a once-daily, add-on treatment in asthma patients who continue to experience symptoms (e.g., wheezing, shortness of breath, chest tightness and cough), despite the use of maintenance therapy including inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA). The studies included in these analyses were double-blind, placebo-controlled, parallel-group trials in adult patients with mild, moderate and severe asthma. A total of 3480 patients were randomized for the five trials to receive tiotropium 5 mcg, 2.5 mcg or placebo in addition to ICS with or without LABA. Three criteria were used to determine whether or not a patient had allergies: total serum immunoglobulin E (IgE, < or =430mcg/L [equivalent to 179.2 IU/L]), blood eosinophils (< or =0.6×10(9)/L), or investigator judgment (No/Yes). Patients were permitted to receive additional background therapy, which varied from trial to trial, and included treatments such as antihistamines, anti-allergic agents, nasal steroids and omalizumab.